Coffee Against Obstipation in Intensive Care Treatment

Coffee might stimulate bowel movement and thus overcome obstipation in intensive care unit (ICU) patients.

Study Overview

• Status: Unknown
• Conditions: Obstipation
• Intervention / Treatment: Dietary supplement: coffee; Dietary supplement: coffee rectally

Detailed Description

Critically ill patients requiring ventilator support frequently suffer from obstipation. We hypothesize that coffee, administered either orally or rectally, might stimulate bowel movement.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Heidelberg, Germany, 69120
    • University Hospital of Heidelberg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• admission to the medical intensive care unit of the Dept. of Gastroenterology at the university hospital heidelberg
• requires ventilator support for an anticipated more than 72 hours
• age older than 18 years

Exclusion Criteria:

• pregnancy
• known allergy to coffee
• mechanical ileus
• presence of enterostoma

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: standard of care; patients receive standard care
Experimental: Coffee orally; patients will receive standard of care plus coffee orally	Dietary supplement: coffee; patients will receive a cup of coffee at room temperature orally twice daily
Experimental: coffee rectally; patients receive standard of care plus coffee rectally	Dietary supplement: coffee rectally; patients receive an enema of two cups of coffee at room temperature once daily; Other Names: Coffee

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Bowel movement rate	participants will be followed for the duration of hospital stay, an expected average of 5 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
time on mechanical ventilation	participants will be followed for the duration of intensive care unit stay, an expected average of 3 weeks
time of stay on ICU	participants will be followed for the duration of hospital stay, an expected average of 5 weeks
lengths of hospitalisation	an average of 5 weeks of hospital stay is expected
in hospital mortality	participants will be followed for the duration of hospital stay, an expected average of 5 weeks
long term mortality	6 months following discharge

Collaborators and Investigators

• Sponsor: University Hospital Heidelberg
• Investigators: Principal Investigator: Christoph Eisenbach, University of Heidelberg, Heidelberg, Germany

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Anticipated): December 1, 2013
• Study Completion (Anticipated): June 1, 2014

Study Registration Dates

• First Submitted: November 10, 2011
• First Submitted That Met QC Criteria: November 14, 2011
• First Posted (Estimate): November 17, 2011

Study Record Updates

• Last Update Posted (Estimate): November 17, 2011
• Last Update Submitted That Met QC Criteria: November 14, 2011
• Last Verified: November 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation
• Other Study ID Numbers: COFFEE